- Reference: 46790
- Job Type: Permanent
- Location: Meath
- Category: Science, Pharmaceutical & Food
The Post Market Compliance Specialist (PMS)is responsible for ensuring the company is compliant with European Medical Device Directive and ISO:13485 with regards to Post Market Vigilance.
Functionally reports into the Regulatory Manager. You will have the responsibility for ensuring a smooth and efficient Post Market Surveillance process. The Post Market Compliance Specialist is responsible for the following main tasks:
- Liaison for all communications with Competent Authorities for Post Market Vigilance.
- Conduct daily complaint handling activities to include assessment of all identified potentially reportable complaints.
- Determine whether high risk complaints are reportable or non-reportable to the relevant Competent Authorities.
- Hold weekly meetings with potentially reportable complaints team (product engineers, clinical, regulatory teams in USA) to gain consensus for reportable complaints to European, MEATI authorities and FDA where appropriate.
- Liaise with Service Centres and investigation sites to ensure accurate and complete investigation and repair data is recorded.
- Conduct follow up for additional information to ensure complaints are documented fully and completely.
- Monitor complaints/product deficiencies, to ensure they are categorised appropriately to high/low risk.
- Notifying, updating and answering queries for all Competent Authorities and relevant Management teams of the progress of the Field Action.
- Such other duties or projects as may be determined from time to time.
For more information or to apply please contact Tina Egan on firstname.lastname@example.org 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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